Clinical Trials Directory

Trials / Terminated

TerminatedNCT01889472

Impact of Interface With/Without Oral Appliance of Sleep Apnea Treatment

Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Laval University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.

Detailed description

Participating subjects will be currently treated by CPAP and low compliance will be assessed according to machine report download demonstrating 3h or less of CPAP usage per night.

Conditions

Interventions

TypeNameDescription
DEVICENasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy

Timeline

Start date
2013-06-01
Primary completion
2017-01-18
Completion
2017-01-18
First posted
2013-06-28
Last updated
2017-05-05

Locations

3 sites across 2 countries: Canada, France

Source: ClinicalTrials.gov record NCT01889472. Inclusion in this directory is not an endorsement.